Medical connector having high flow rate characteristics

ABSTRACT

A soft grip medical connector can include a housing and a flexible member. The housing has a lumen extending through it from an upstream end to the downstream end. The flexible member includes a valve portion integrally formed with a sleeve portion. The valve portion is positioned within a section of the housing and can control a flow of fluid through the housing lumen. The sleeve can be inverted to envelop some or all of the outer surface of the housing. The sleeve can include a gripping portion integrally formed with the valve portion. The connector can also create a positive pressure in the lumen upon removal of a syringe or other medical device from the upstream end of the connector.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.11/267,822, filed Nov. 4, 2005 now abandoned, which claims the benefitof U.S. Provisional Application No. 60/625,644, filed on Nov. 5, 2004,and U.S. Provisional Application No. 60/654,250, filed on Feb. 18, 2005,the entireties of which are hereby incorporated by reference.

BACKGROUND OF THE INVENTIONS

1. Field of the Invention

The inventions disclosed herein relate in general to the field ofmedical connectors, and in particular to needle-less medical connectors.

2. Description of the Related Art

The manipulation of fluids for parenteral administration in hospitalsand medical settings routinely involves the use of connectors forselectively facilitating the movement of fluids to or from patients. Forexample, a connector may be attached to a catheter that leads to a tippositioned within a patient, and various connectors may be attached toone or more tubes and medical implements to control the fluid flow to orfrom the patient.

Needle-less connectors are typically structured so that a medicalimplement without a needle can be selectively connected to such aconnector for providing fluid flow between a patient and a fluid sourceor receptacle. When the medical implement is removed, the connectorcloses, effectively sealing the catheter connected to the patientwithout requiring multiple injections to the patient and withoutexposing health care professionals to the risk of inadvertent needlesticks. The medical implement used with the connector may be a tube orother medical device such as a conduit, syringe, IV set (both peripheraland central lines), piggyback line, or similar component which isadapted for connection to the medical valve.

Many existing medical connectors can be relatively difficult to grasp byhealth care professionals during use. In most applications, medicalconnectors are designed to be relatively small to minimize the cost ofmanufacturing and to minimize the amount of fluid “dead space” insidethe connectors. Moreover, most medical connectors include a housing witha hard, smooth outer surface. As a result, it is sometimes uncomfortablefor health care professionals to tightly pinch their fingers around theconnectors and firmly grasp them during medical procedures in arepetitious manner. Because health care professionals use suchconnectors very frequently during patient care, enhancements in theirability to effectively grasp the connectors can result in significantimprovement in the time and effort required to use them. Additionally,the existing hard-surface medical connectors can be uncomfortableagainst a patient's skin. This discomfort can become especiallypronounced when a patient requires frequent medical attention involvingthe use of medical connectors, such as hemodialysis.

Additionally, many existing medical connectors at least partiallyobstruct fluid flow with complex flow passageways including variousturns, bends, and corners. These obstructions can result in a fairly lowflow rate. The obstructions can also damage blood platelets.

Further, many existing connectors permit some degree of retrograde fluidflow upon the disconnection of these medical devices from the valve.These connectors typically include an internal space through which afluid may flow from the medical implement to the catheter attached tothe connector. When the medical implement is attached to the connector,it typically occupies a portion of this internal valve space, displacinga certain amount of fluid within the connector. When the medicalimplement is disconnected, a vacuum is created by the removal of theportion of the medical implement from the internal space of theconnector, which tends to draw fluid up through the line from thepatient toward the connector to fill the space left by the removal ofthe implement.

This regression of fluid has certain disadvantages. When the connectoris attached to a fluid line leading to a patient, retrograde movement offluid through the line towards the space in the connector has the effectof drawing a small amount of blood away from the patient in thedirection of the connector. The blood thus drawn into the catheter may,over time, result in a clog in the catheter near its tip, potentiallylimiting the effectiveness of the catheter tip.

The likelihood of blood clogging the tip of a catheter is heightenedwhen the inner diameter of the catheter is small. In parenteralapplications, such smaller-diameter catheters are used frequently due totheir numerous advantages. For example, smaller catheters reduce thetrauma and discomfort caused by insertion into a patient. Because thesecatheters have small lumens, even a small suction force may draw fluidback a comparatively large distance through the catheter toward theconnector.

Further, in some existing medical connectors, there are gaps between aninternal sealing member and the outer housing of the connector. Thesegaps may allow bacteria, debris, or disinfectant solution to enterthrough the opening into the interior of the connector and potentiallyreach the flow of fluid to or from the patient.

SUMMARY OF THE INVENTIONS

Certain embodiments of the present invention provide a soft-grip medicalconnector comprising a housing with an upstream end, a downstream end, alumen extending through a central portion of the housing, and a flexiblemember. In some embodiments, the flexible member has a valve portionintegrally formed with a gripping portion. The valve portion ispositioned within a portion of the housing. The valve portion isconfigured to control a flow of fluid through the housing lumen. Thegripping portion covers at least a portion of an outer surface of thehousing.

In some embodiments, a medical fluid connector comprises a cylindricalbody, a valve portion, and a sleeve portion. The cylindrical body has anouter wall with a plurality of flanges extending radially therefrom anda lumen extending through a portion thereof. The valve portion providesa closeable seal between a first end and a second end of the cylindricalbody. The sleeve portion can be unitarily formed with the valve portionand can surround a substantial portion of an outer surface of thecylindrical body.

Methods of forming a gripping and/or sealing portion of a medical deviceare also provided. In some embodiments, a method comprises injecting anuncured material into a mold, thereby molding a first preform from asubstantially flexible material. The preform is removed from the preformmold, and a second preform is molded (though not necessarily in the samemold as the first). The first preform and the second preform are theninserted into a final mold, and an uncured material is injected into thefinal mold in order to over-mold the first and second pre-forms into afinal structure having a valve member and a sleeve portion extendingfrom the valve member.

Methods of making a medical fluid connector are also provided. In someembodiments, the methods comprise the steps of forming a valve memberwith a sleeve extending therefrom, the valve and sleeve being integrallyformed of a substantially flexible material and forming a relativelyrigid housing. A portion of the valve member is inserted into a cavityof the housing such that the sleeve extends from the housing member. Thesleeve is then inverted to cover or surround at least a portion of anouter surface of the housing member.

In embodiments of a method of using a soft-grip connector, thedownstream end is connected to a first medical implement such as acatheter. A second medical implement is inserted into an opening in theupstream end of the connector. Upon introduction of the second medicalimplement into the connector, in certain embodiments, the valve memberexpands, creating a larger internal volume. Fluid from the secondmedical implement is permitted to flow into the valve member. In someembodiments, this introduction of fluid causes further expansion of thevolume inside the valve member, and as the fluid flow diminishes orstops, the inside volume of the valve member contracts.

As the second medical implement is withdrawn from the connector, theinternal volume of the valve member also decreases. In some embodiments,the valve member can rapidly return to its original state (i.e., beforeinsertion of the second medical implement). A region inside of the valvemember near the upstream end is narrower than a region near thedownstream end to impede the flow of fluid in the upstream direction andencourage the flow of fluid in the downstream direction. In this way,fluid inside the connector is forced toward the downstream end of theconnector in the direction of the patient, creating a positive floweffect and minimizing regression of fluid back into the valve. Variousconfigurations of positive-flow valves are disclosed in U.S. Pat. No.6,695,817 and U.S. Patent Application Publication No. 2004/0006330,owned by ICU Medical, Inc., and such documents are incorporated hereinby reference and form a part of this specification for all that theydisclose.

In many embodiments, the connector is small yet easily grippable. Theouter sleeve can be made, for example, of silicone rubber, which createsa desirable degree of anti-slip friction against standard rubber glovesworn by health care professionals. In some embodiments, the contours ofthe connector in the region near the upstream end are generally smoothand seamless due to the integral formation of the flexible outer sleeveand the valve member. In this configuration, it is less likely thatbacteria or other debris will gather in areas where fluid flow passesthrough to the patient and it is easier and more effective to swab suchareas with antiseptic. The integral formation of the valve member andouter sleeve also simplifies, and increases the cost-effectiveness, ofthe manufacturing processes.

BRIEF DESCRIPTION OF DRAWINGS

Having thus summarized the general nature of the invention, certainpreferred embodiments and modifications thereof will become apparent tothose skilled in the art from the detailed description herein havingreference to the figures that follow, of which:

FIG. 1 is a perspective view of one embodiment of a soft-grip medicalconncetor including an outer sleeve surrounding a housing member;

FIG. 2 is a perspective view of one embodiment of a housing member of asoft-grip medical connector;

FIG. 3 is a top plan view of the housing member of FIG. 2;

FIG. 4 is a bottom plan view of the housing member of FIG. 2

FIG. 5 is a transverse cross-sectional view of the housing member ofFIG. 2 taken through line 5-5 (shown in FIG. 3);

FIG. 6 is a transverse cross-sectional view of the housing member ofFIG. 2 taken through line 6-6 (shown in FIG. 3);

FIG. 7 is an exploded perspective view of another embodiment of housingmember of a soft-grip medical connector;

FIG. 8A is a perspective view of a first housing portion of the housingmember of the housing member of FIG. 7;

FIG. 8B is a perspective view of the first housing portion of FIG. 8Afrom a reverse angle;

FIG. 9A is a perspective view of a second housing portion of FIG. 7;

FIG. 9B is a perspective view of the second housing portion of FIG. 9Afrom a reverse angle;

FIG. 10 is a transverse cross-sectional view of the housing member ofFIG. 7 taken through line 10-10;

FIG. 11 is a transverse cross-sectional view of the housing member ofFIG. 7 taken through line 11-11;

FIG. 12 is a perspective view of a flexible member including a valvemember and a sleeve connected to the valve member;

FIG. 13 is a cross-sectional view of the connector of FIG. 12, takenthrough line 13-13;

FIG. 14 is a cross-sectional view of the flexible member of FIG. 12,taken through line 14-14;

FIG. 15 is a perspective view of one embodiment of a preform for use inmanufacturing some embodiments of a flexible member;

FIG. 16 is a perspective view of another embodiment of a flexible memberincluding a valve member and a sleeve connected to the valve member;

FIG. 17 is a cross-sectional view of the flexible member of FIG. 16,taken through line 17-17;

FIG. 18 is a cross-sectional view of the flexible member of FIG. 16,taken through line 18-18;

FIG. 19 is a perspective view of a third embodiment of a flexible memberhaving a valve member and a sleeve connected to the valve member;

FIG. 20 is a cross-sectional view of the flexible member of FIG. 19,taken through line 20-20;

FIG. 21 is a cross-sectional view of the flexible member of FIG. 19,taken through line 21-21;

FIG. 22 is a perspective view illustrating an assembly of a flexiblemember with a housing member;

FIG. 23 is a perspective view illustrating the sleeve of the flexiblemember adjacent to the housing member, with the valve member of theflexible member inserted into the housing member.

FIG. 24 is a cross-sectional view of an assembled soft-grip medicalconncetor;

FIG. 25 is a cross-sectional view of a soft-grip medical connector takenat about 90° relative to the cross-section of FIG. 24.

FIG. 26 is a cross-sectional view of the connector of FIG. 24 with asyringe connected thereto; and

FIG. 27 is a cross-sectional view of the connector of FIG. 24 taken atabout 90° relative to the cross-section of FIG. 26.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

With reference to the attached figures, certain embodiments and examplesof soft-grip medical connectors will now be described. Although certainembodiments and examples of a soft-grip connector are shown anddescribed as including positive-flow valves, certain aspects andadvantages of the systems and methods described herein can beadvantageously applied to numerous other fluid connector designsincluding those without positive-flow characteristics.

Referring now to FIG. 1, the illustrated embodiment of a medicalconnector 10 comprises a substantially rigid housing 12 with a flexiblemember 80 that has been streched over the outer surface of the housing12 to provide a soft, grippable outer surface 22. A slit opening 100 isformed at an upstream end 16 of the flexible member 80. The upstream endof the flexible member 80 surrounding the housing 12 provides a surfacethat is easily cleaned, and is substantially free from cavities orrecesses in which contaminants may collect. While as illustrated, theupstream end of the flexible member 80 surrounds the entirecircumference of the housing 12, it is contemplated that in otherembodiments, the upstream end of the flexible member maycircumferentially surround substantially all of the housing 12, or cancircumferentially surround a portion of the housing 12 such asapproximately three-quarters, approximately one-half, or less. In otherembodiments, the flexible member 80 can be segmented to surroundmultiple portions of the housing 12. For example, the flexible member 80can have one or more openings or perforations that expose a portion ofthe underlying housing 12 beneath the flexible member 80, and/or theportions of the flexible member 80 on the outside of the housing 12 canbe made of strips or bands that contact the housing 12. The outersurface of the flexible member 80 can cover internal portions of theflexible member 80, such as lateral extensions 84 (discussed in furtherdetail below), to prevent interference with those portions during use,thereby providing for more consistent functionality of the flexiblemember 80.

Referring now to FIGS. 2-11, embodiments of a housing 12 are described.FIGS. 2-6 depict one embodiment of a housing 12 for use in a soft-gripmedical connector. FIGS. 7-11 depict another embodiment of a housing foruse in a soft-grip medical connector. Many other embodiments can also beformed by using or combining one or more features of the disclosedembodiments.

With reference to the housing depicted in FIGS. 2-6, the housing 12comprises an upper cavity 42 for receiving a flexible member 80, andinterfaces 16, 30 for joining the connector to a variety of medicaldevices. An upper housing 40 generally comprises a cylindrical wall 44having longitudinal slots 46 positioned on opposite sides, e.g.,oriented at about 180° relative to one another. At a lower end, theupper housing 40 joins a base member 48 which comprises a lower Luerconnector 30 (see, e.g., FIGS. 5 and 6). During storage and shipping ofa sterilized connector 10, a protective cap (not shown) can be attachedto the lower Luer connector 30 to maintain its sterility before use. Thecap is generally removed by a health care professional immediatelybefore connecting the lower Luer connector 30 to a medical implement.

As illustrated, embodiments of a housing member 12 can also include aplurality of ring sections 60 extending radially outwards from the outersurface of the cylindrical wall 44 of the upper housing 40. In someembodiments, the rings 60 are progressively smaller in diameter from top60 a to bottom 60 c. In still other embodiments, the number, size, andconfiguration of the rings 60 can be modified in many other ways.

Flanges 62 can also be provided at the intersections between the rings60 and the slots 46. The flanges 62 prevent lateral extensions 84 of theflexible member 80 (see, e.g., FIG. 23), when inserted into the upperhousing 40, from snagging or catching on the edges of the rings 60 atthe points where such rings 60 are bisected by the longitudinal slots46. The rings 60 and flanges 62 are generally configured to retainportions of a sleeve 20 on the flexible member 80, as will be discussedin further detail below.

As illustrated in FIGS. 1, 5 and 6, the progressively smaller diameterrings 60 coupled with a frustoconically shaped skirt 52 generally resultin an “hourglass” shaped housing. This advantageously assists inproviding an easily grippable connector. The smaller-diameter regionnear the lower end of the upper housing 40 can be grasped between thethumb and index finger of a health care professional. In the region ofthe rings 60, the progressively larger diameter regions above and belowthe smaller-diameter region make it less likely that the person's gripwill slide along the outside surface of the connector 10 when othermedical implements are attached to it or detached from it. In addition,other gripping surfaces such as bumps, ridges, and other types ofindentations or protrusions can be provided on the outside surface ofthe sleeve 20 in the region where the health care provider's fingers areexpected to grasp the connector 10.

The dimensions of the housing 12 preferably allow for a compactconnector. Advantageously, a compact connector is relatively low cost asit requires a relatively small amount of material to manufacture.Further, the compactness typically results in a lightweight connector,thus reducing irritation to a patient when a connector is rested on orhanging from the patient for a relatively long duration use. Forexample, in some embodiments, the housing 12 has a height from anupstream end 16 to a downstream end of a Luer cannula 32 of betweenabout 0.400″ and 1.200″. In other embodiments, the height of the housing12 can be between about 0.500″ and 1.000″. In still other embodiments,the height is less than 1.000″. The height of the upper housing 40 froman upstream end 16 to the lower Luer connector 30 is between about0.500″ and 0.750″. Preferably, the upper housing 40 comprisesapproximately three-fourths to four-fifths of the overall height of thehousing 12. A Luer cavity 74 has a height extending from the lower end36 of the housing 12 to a lower surface of the base member 48. Incertain embodiments, the height of the Luer cavity is betweenapproximately 0.150″ and 0.350″. In other embodiments, the height of theLuer cavity is less than approximately 0.400″. In a certain embodiment,the height of the Luer cavity is approximately 0.220″. Preferably, theheight of the Luer cavity 74 corresponds to a length of a Luer connectorto be inserted in the Luer cavity 74 such that the Luer connector can beflushly inserted into the Luer cavity 74. Preferably, the height of theLuer cavity 74 comprises from between approximately one-eighth toapproximately one-third of the height of the housing 12. In certainembodiments, a Luer cannula 32 extends past the lower end 36 of thehousing 12 approximately 0.050″ to 0.150″. In other embodiments, theLuer cannula 32 extends past the lower end 36 approximately 0.80″ to0.120″. In a certain embodiment, the Luer cannula 32 extends past thelower end 36 approximately 0.093″. Preferably, the Luer cannula is sizedand configured to couple with a Luer connector to be inserted into theLuer cavity 74

The dimensions of the rings 60 and other housing structures correspondto features of the sleeve 20 as will be further described below. Forexample, in some embodiments, the cylindrical wall 44 has an outerdiameter of between about 0.200″ and about 0.300″, preferably betweenabout 0.250 and about 0.275, and in one particular embodiment, adiameter of about 0.265. In such embodiments, the upper ring 60 a has aheight ‘h’ (i.e. the difference between the outer diameter of the ringand the outer diameter of the cylindrical upper housing) of about 0.110″(±0.02″), the middle ring 60 b has a height of about 0.093″ (±0.02″),and the lower ring 60 c has a height of about 0.073″ (±0.02″). Thus, incertain embodiments, the housing 12 includes a generallyhourglass-shaped body defined by the cylindrical wall 44 and the rings60 a, 60 b, 60 c and having a maximum diameter of between about 0.310″and 0.410″, preferably between about 0.360″ and 0.385″, and in oneparticular embodiment, about 0.375″. Other dimensions within and outsideof the above ranges can also be used depending on the particularapplication desired.

As shown, for example, in FIGS. 1, 2 and 5, the housing 12 can alsoinclude protrusions 70 such as lugs for receiving a threaded medicalconnector such as a Luer connector of a medical device such as asyringe. In the illustrated embodiment, the protrusions 70 lugs aregenerally rectangular in shape. The lugs can also have substantiallyrounded or beveled edges so as to prevent damage to the sleeve 20 of theflexible member 80 after it is stretched over the outside of the housing12, as described in greater detail below. The sleeve 20 can includewindows 126 configured to allow the protrusions 70 to protrude throughthe flexible member 80, while preferably tightly engaging the peripheryof the protrusions 70, when the sleeve 12 is inverted (as will bediscussed in further detail below). In other embodiments, theprotrusions 70 can comprise other shapes and configurations as desired.In some embodiments without windows 126, the protrusions 70 are sized tocooperate with a thickness of the sleeve, such that the protrusions 70form a lump in the sleeve sufficient to engage a female thread of a Luerconnector to be attached to the upstream end 16 of the connector 10.

In some embodiments, the lower housing interface comprises a Luerconnector 30 to facilitate joining the connector 10 to medical deviceswith female Luer connectors. The Luer connector 30 of the housing 12 cancomprise a hard cannula 32 extending downwardly from the lower end 36 ofthe housing 12 to provide a connection with another medical device, suchas a catheter hub. Other interfaces and connections can also be used inplace of the Luer connector 30, such as Luer slip connections, barbedhose fittings, etc.

As shown in FIGS. 5 and 6, the housing also includes an interior cannula50 extending into the upper housing cavity 42. The interior cannula 50comprises a lumen 45 extending through the base member 48 and throughthe Luer cannula 32 of the lower Luer connector 30. The lower Luerconnector 30 also includes a skirt 52 which extends downwards from thebase member 48 and typically comprises internal threads 56 or otherfeatures for securing the connector 10 to another medical device. Theskirt 52 can comprise a taper from a narrower upper portion to alarger-diameter lower portion. In some embodiments, the skirt 52 alsoincludes an incut annular groove 54 around the perimeter of the skirt 52at a lower portion thereof. This annular groove 54 can be used to retaina portion of the sleeve as will be described in further detail below.

In certain embodiments, it is desirable to provide vents 72 (see FIG. 4)between the upper housing cavity 40 and the cavity 74 defined by thelower Luer skirt 52. Since the outer surfaces of the housing 12 aregenerally in contact with the sleeve 20 in the final assembly (and, asdiscussed below in connection with assembly of the medical connector 10,in certain embodiments, the sleeve 20 can cover the entire outersurface, or nearly the entire outer surface, of the housing 12), suchventilation between the upper housing 40 and the cavity 74 is helpful inallowing air, gaseous sterilizing agents or other gases to flow freelyinto and/or out of the upper housing cavity. This ventilation can beparticularly helpful when and as a medical implement is inserted intothe slit opening 100 of the connector 10 and the flexible member 80expands, diminishing the volume between the outer surface of theflexible member 80 and the inner wall of the upper housing 40. The vents72 may also allow moisture and other liquids to flow freely into and/orout of the upper housing cavity, thus reducing the risk that a volume ofliquid could become trapped in the upper housing 40 and restrictexpansion of the flexible member 80, provide a hospitable environmentfor the growth of unwanted bacteria, or otherwise adversely affect theoperation of the medical connector 10. Without venting, such insertionof the medical implement could be met with resistance, creating unduewear on the flexible member 80 and requiring additional effort to usethe connector 10. Similarly, recessed vents 76 can be provided in thelower end 36 of the Luer skirt 52 to allow air or other gases to escapefrom the interior of the Luer cavity 74 while the connector 10 isattached to another medical device. Additionally, the recessed vents 76allow air or other ambient gases to enter the Luer cavity 74 while theother medical device is removed from the medical connector 10 such thatthe medical device does not become vacuum locked to the medicalconnector 10. The recessed vents 76 also allow water, cleaning ordisinfecting solutions, or other liquids to escape the Luer cavity 74while the medical connector 10 is connected to another medical device.In some embodiments, it can be desirable to provide ventilation holes inthe sleeve 20 itself.

With reference to FIGS. 7-11, in certain embodiments, the soft-gripmedical connector comprises a housing formed of more than one housingportion. In the illustrated embodiments, the housing is formed of afirst housing portion 41 and a second housing portion 51. FIG. 7illustrates an exploded perspective view of a two-piece housing. FIGS.8A and 8B are perspective views of the first housing portion 41, andFIGS. 9A and 9B are perspective views of the second housing portion 51.

In some embodiments, a two-piece housing may include many or all of thestructural features of the housing illustrated in FIGS. 2-6 anddescribed above. In other embodiments, the housing may include more thantwo pieces. The two-piece housing illustrated in FIGS. 7-11 includesprotruding lugs 71 for receiving a threaded medical connector such as aLuer connector of a medical device such as a syringe. The first housingportion 41 also includes longitudinal slots 49 oriented at approximately180° relative to each other. In some embodiments, a different number ofslots or ridges can be provided and the slots or ridges can be of sizesor positions. The first housing portion 41 defines an upper cavity 43for receiving a flexible member 80. The second housing portion 51includes a threaded Luer cavity 59. Additionally, the second housingportion may include recessed vents 77 in the lower surface of the Luercavity 59. The second housing portion includes an interior cannula 53comprising a lumen 55 extending through the second housing portion 51.Moreover, the second housing portion may include vents 57 between thefirst housing portion 41 and the second housing portion 51. Further, itis contemplated that a two-piece housing can have dimensionscorresponding to the ranges discussed above with respect to theembodiments of one-piece housing 12 illustrated in FIGS. 2-6. Therefore,in certain embodiments of medical connector, a two-piece housing couldbe used interchangeably with a one-piece housing

The two piece housing illustrated in FIGS. 7-11 also can also includeadditional features. For example, the two-piece housing can includevarious alignment and coupling features to ease assembly of the firsthousing portion 41 with the second housing portion 51 into a completehousing. For alignment, the second housing portion may include at leastone ridge 65, and the first housing portion at least one correspondingrecess 63. As illustrated in FIG. 7, the ridge 65 and sidewall 63 areconfigured to align the first housing portion 41 in a desiredorientation with the second housing portion 51 during assembly of thehousing. To retain the housing in a coupled orientation, the firsthousing portion 41 includes at least one tab 89, and the second housingportion 51 includes at least one recess 85 configured to receive the tab89. As illustrated, the tab 89 has a wedge-shaped profile including alead-in surface and an interference surface such that the lead insurface facilitates insertion of the tab 89 into the recess and theinterference surface prevents withdrawal of the tab 89 from the recess85. While described herein and illustrated in terms of certainstructures, it is contemplated that other alignment and couplingfeatures can be used to couple the two housing portions 41, 51.

In the housing illustrated in FIGS. 7-11, the assembly of first andsecond housing portions 41, 51 results in a space 61 between the housingportions 41, 51. Advantageously, the space 61 may be sized andconfigured to retain an end of a flexible member 81. Thus, in such aconfiguration, the rings 60 used in one-piece housing 12 (FIGS. 2-6)need not be present on a two-piece housing to reduce slippage of thehousing relative to a flexible member 80 disposed thereon. In order tofurther reduce slippage of a flexible member 80 relative to the housing,an area of the first housing portion adjacent the lugs 71 may include arecess 73 to receive an adhesive such that the flexible member 80 may beadhered to the housing. The adhesive and housing materials should bechosen to be compatible. For example, a silicone-based adhesive may beapplied to adhere a glass-reinforced thermoplastic polyester resinhousing to a silicone rubber sleeve 20. In addition to the slippagereduction noted above, the two-piece housing depicted in FIGS. 7-11 maybe manufactured quickly and inexpensively in two separate one-stepmolding processes as opposed to a two-step molding process required tomanufacture a more complex single-piece housing.

As illustrated in FIGS. 12-14, in some embodiments, the valve member 14and sleeve 20 are unitarily formed in a flexible member 80. The flexiblemember 80 is shown removed from the housing 12 to emphasize details.Some embodiments of valve member 14 have a seal body 82 which may takethe form of a slab-like structure that is relatively thin in onedimension and relatively wide in another. The valve member 14 isconfigured to selectively seal the connector. The term “seal” is usedherein for convenience to refer to structures capable of impeding fluidflow but does not necessarily denote that such structures, either aloneor in combination with other structures, form a barrier that iscompletely impermeable to fluid flow. In some embodiments, the body 82comprises lateral extensions 84 extending laterally from the body 82.The body 82 can also comprise a flat, generally rectangular neck 86 anda transverse flange 90. In some embodiments, the sleeve 20 is integrallyformed with the flange 90 and extends axially away from the seal body82.

The neck 86 is positioned between first and second lateral extensions84, which each have shoulders 92 comprising those portions of thelateral extensions nearest the flange 90. The body 82, neck 86, flange90, and sleeve 20 can thus form an integral unit. The body 82 isgenerally configured to include a narrow passageway or slit 94 extendingthrough the body 82. The slit 94 generally extends through the body 82including the neck 86 and the flange 90. In FIG. 14, the verticalcross-sectional plane of the drawings coincides with the vertical planeof the slit 94, revealing the wide horizontal width of the slit 94 onthe downstream end in this dimension. The slit 94 also includes taperingsides 95, and a narrower neck 97. FIG. 13 demonstrates the narrowness ofthe slit 94 in a cross-sectional plan orthogonal to the cross-sectionalplane of FIG. 14.

As will be described more fully below, the valve member 14 is insertedinto the cavity 42 of the housing 12. The slit 94 is generally sized andshaped to permit insertion of a cannula of a syringe or other medicaldevice therein. The connector can be adapted to receive an ANSI standardsyringe Luer tip. In some embodiments, the slit 94 is configured toassist in producing a valve that exhibits positive flow characteristics.

The slit 94 extends from the slit opening 100 in the flange 90 to a leadlumen 102 formed in a the downstream end of the body 82 opposite theflange 90. In some embodiments, the lead lumen 102 can be substantiallycylindrical and centered about an axis that is substantially parallel toor collinear with the longitudinal axis of the valve member 14. The leadlumen 102 can also be provided with an enlarged external diametersection 104 (e.g. see FIG. 14) configured to aid in positioning the leadlumen 102 over the interior cannula 50 of the housing 12 and to avoidunduly diminishing the cross-sectional area for fluid flow after theflexible member 80 is so positioned.

As illustrated in FIG. 13, some embodiments of the slit 94 can besubstantially planar and have a very small thickness in the undisturbedstate (i.e. when a syringe cannula is not inserted into the valve member14). The slit 94 thus forms a selectively restricted fluid flow pathfrom the slit opening 100 to the lead lumen 102. Preferably, the flowpath permits either no fluid, or a clinically negligible amount offluid, to pass through the flexible member 80 under the various standardfluid pressure conditions of patient treatment.

The slit 94 is generally configured to provide a sealable fluid pathwaybetween the slit opening 100 and the lead lumen 102. In someembodiments, the slit 94 can be configured as shown and described hereinor as shown and described in any of the patents and applicationsincorporated herein by reference. The slit 94 is typically made to haveessentially no space between adjacent faces of the slit. Examples ofmethods for making a suitable seal are described in further detailbelow.

In the embodiment illustrated in FIG. 12, the lateral extensions 84generally comprise polygonal, angular shapes, although other suitableshapes can be used in view of particular design objectives. The lateralextensions 84 are generally configured to provide structures thatinteract with portions of the housing 12 in order to retain the valvemember 14 in the housing 12 at a desired orientation. As illustrated inFIG. 12, dimples 110 can be formed in the flat surfaces of the lateralextensions 84. In other embodiments, dimples 110 can be formed onanother surface of the valve member 14, and, in still other embodiments,the valve member 14 does not include dimples 110. The dimples 110 can beused for retaining and positioning the valve member 14 and lateralextensions 84 during molding and assembly of the connector as will befurther described below.

In the embodiments of FIGS. 13 and 14, a sleeve 20 extends axially fromthe transverse flange 90 of the valve member 14 to the opposite end ofthe flexible element 80. The sleeve 20 can comprise a first section 112with a first diameter D1 substantially corresponding to the diameter ofthe transverse flange 90, and a second section 114 with a seconddiameter D2 that is slightly larger. In some embodiments, the length ofthe first section 112 having the first diameter D1 is approximatelyequal to a distance between the upstream end 16 of the housing 12, andthe upper ring 60 a of the housing 12. The second section 114 of thesleeve 20 is typically sized to be approximately the same diameter as,or slightly smaller than, the narrowest portion of the hourglass-shapedhousing. Thus, when the sleeve 20 is inverted and stretched to surroundthe housing 12, the sleeve 20 will preferably cling tightly to theexterior surface of the housing along substantially the entire length ofthe housing 12.

To retain the sleeve 20 in an inverted position surrounding the housing12, the sleeve 20 can be provided with retaining structures to engageportions of the housing 12. Such retaining structures can include any ofa variety of structures, such as protrusions, ribs, ridges, andconstrictions. In the embodiments illustrated in FIGS. 12-14, the sleeve20 comprises a plurality of protrusions 120. In other embodiments,continuous annular ribs can be used in place of the protrusions. Suchannular ribs may tend to buckle when the sleeve is turned inside-out,thus causing ripples and irregularities in the outer surface of thefinally assembled device. Thus, rows of protrusions 120 such as thoseillustrated in FIG. 12 are used in many embodiments to allow the sleeve20 to lie more smoothly on the outer surface of the housing 12. The rowsare generally configured such that adjacent protrusions abut one anotherwithout deforming the sleeve 20 when the sleeve 20 is inverted. Each ofthe protrusions 120 can have many shapes including rectangular,circular, and/or elliptical shapes.

The protrusions 120 can be provided in annular rows generally configuredto correspond to the spaces between the rings 60 of the housing 12. Thelength of each row is generally also sized to allow the protrusions tolie between the linear flanges 62 adjacent the slots 46. In otherembodiments, the sleeve protrusions 120 and/or the rings 60 and flanges62 of the housing 12 can be provided in any pattern of cooperatingstructures to allow the sleeve 20 to be retained against axial and/orrotational movement relative to the housing 12. For example, in someembodiments, the sleeve 20 further comprises recesses or windows 126 forreceiving and surrounding portions of the housing, such as the Luerprotrusions 70 (see FIG. 1). In other embodiments, as discussed abovewith reference to the two-piece housing of FIGS. 7-11, the housing doesnot have rings 60, so the flexible member need not have protrusions (seeFIGS. 16-18).

In the illustrated embodiment, the sleeve 20 comprises a constriction122 surrounding the opening 124 of the sleeve 20. The constriction 122generally comprises a section of the sleeve with a reduced diameter ascompared to the second section 114. The constriction 122 can beconfigured to engage a feature on the housing 12 such as the annulargroove 54 (see e.g. FIGS. 24 and 25) when the sleeve 20 is inverted overthe housing 12. In other embodiments, the constriction 122 can beconfigured to engage and be retained by a space 61 between a firsthousing portion 41 and a second housing portion 51 (see FIGS. 10 and11).

As described previously, some embodiments of a sleeve 20 can be providedwith one or more windows 126 to accommodate and surround one or morestructures on the housing such as protrusions 70 (also referred to asLuer lugs) or sized to receive a standard Luer connector. In suchembodiments, the windows 126 can be molded to include thicker edges toprevent undesirable tearing of the sleeve material during assembly oruse.

Moreover, as previously described, in some embodiments the sleeve 20 isnot formed integrally with the valve member 14. The sleeve 20 can alsobe formed by adhering, coating, or otherwise providing an outsidesurface on the housing 12 with a suitable gripping region (instead ofmechanically stretching a separately formed sleeve member over theoutside surface of the housing 12). The sleeve 20 can also be formed asa band or clip that extends around only the portion of the housing 12where the fingers of the health care provider are expected to grip theconnector 10. Also, in certain embodiments, the connector 10 may beconstructed without a sleeve 20.

In the embodiments depicted in FIGS. 16-18, a flexible member 81includes at least one stiffening rib 87 oriented substantially along alongitudinal axis of the valve member 14 and protruding transversely tothe flat surfaces of the lateral extensions 84. FIG. 16 illustrates aperspective view of various embodiments of flexible member 81 includingtwo stiffening ribs 87, and FIGS. 17 and 18 illustrate cut-away views ofthe flexible member 81 of FIG. 16. In the illustrated embodiments, theflexible member 81 is configured to be assembled with a housing lackingrings 60 as the flexible member 81 does not include any protrusions 120(see FIGS. 12-14). In other embodiments, a flexible member can includeboth a stiffening rib 87 and protrusions 120 for application to ahousing having rings 60 such as is illustrated in FIG. 2.

The stiffening ribs 87 can provide resiliency and durability to thevalve member 14. In some embodiments, the ribs 87 can help the valvemember 14 to resist crumpling in a substantially longitudinal directionupon insertion of a medical implement into the slit opening 100. Suchcrumpling could block or restrict fluid flow, prevent the connector fromclosing, or otherwise result in some degree of inconsistent performance.Since the crumpling tendency could be exacerbated by aging of a medicalconnector and repeated usage cycles, the stiffening ribs can greatlyextend the lifespan of a valve member 14 in a medical connector. In someembodiments, additional structures and/or materials can be used in themedical connector 10, either in combination with or absent stiffeningribs 87, to resist crumpling of the valve member 14. For example, thevalve member 14 may be constructed of a material selected to be flexibleenough to permit insertion of a medical implement into the slit opening100, but stiff enough to resist crumpling over repeated usage cycles.Likewise, a desired balance between flexibility and valve longevity andresistance to crumpling may be achieved by selecting a desired thicknessof the valve member 14 (with relatively thicker material used in thevalve member 14 increasing the valve longevity and crumple resistance atthe expense of flexibility and ease of insertion of medical implementsinto the slit opening 100). For example, in some embodiments, thethickness of the wall of the valve member 14 across most, nearly all, orall of its outside surface area can be about as thick as the wall of thevalve member 14 plus a stiffening rib 87. In some embodiments, thethickness of the wall of the valve member 14, in at least some regions,is at least as large as, or at least about 1½-2 times as large as, thediameter of the lead lumen 102.

Another embodiment of flexible member 83 for use in a soft-grip medicalconnector that is configured to extend the usage lifespan of a valvemember is illustrated in FIGS. 19-21. FIG. 19 illustrates a perspectiveview of the flexible member 83. As illustrated in FIG. 19, the flexiblemember 83 may share many external features with other embodiments offlexible member 80, 81 as previously discussed (including but notlimited to those that are illustrated in FIGS. 19-21). For example, theflexible member 83 includes a valve member 153 and a sleeve 165. Incertain embodiments, the sleeve 165 includes protrusions 157 forcoupling with corresponding flanges on a housing. The sleeve 165includes a constriction 161 surrounding an opening 163. The sleeve caninclude one or more windows 159 to accommodate and surround one or moreprotrusions 70 or other structures on the housing. The flexible memberincludes a transverse flange 155, a neck 167, and lateral extensions169. As illustrated in FIGS. 20 and 21, the flexible member 83 includesa lead lumen 173 having a downstream opening 151.

As illustrated in FIGS. 20 and 21, which present cut-away views of theflexible member 83 of FIG. 19, the internal structure of the embodimentsof flexible member 83 illustrated in FIGS. 19-21 can include featuresabsent from other embodiments of flexible member 80, 81 illustratedherein. The valve member 153 of the flexible member comprises a pair ofopposing sidewalls 177, 179 that intersect at an upstream end of thevalve member 153 to form a slit 171 configured for insertion of amedical implement. In an undisturbed state, the slit 171 provides asealed closure of the medical device to prevent the passage of fluidtherethrough. In the downstream direction, the sidewalls 177, 179diverge such that in an undisturbed state, a passage 175 defined by thevalve member has a non-zero volume. Thus, unlike thepreviously-described flexible member 80, 81 embodiments, this flexiblemember 83 does not have a passage that is substantially planar in anundisturbed state.

In some embodiments, this non-zero volume of the passage 175 in anundisturbed state can prevent the illustrated embodiment of flexiblemember 83 from exhibiting positive flow characteristics when a medicalimplement inserted completely into the slit 171 is removed under certaincircumstances. This passage 175 configuration has certain otheradvantages. As previously noted, the flexible member 83 resistscrumpling. The divergence of the sidewalls 177, 179 enhances thedurability of the valve member 153 as compared with planar sidewalls ofother flexible member 80, 81 embodiments.

Additionally, the slit 171 of the flexible member 83 has a relativelysmall region of contact between the sidewalls 177, 179. The small regionof contact results in a corresponding small resistance to flow in anundisturbed state. Thus, the flow through the valve member can bequickly initiated by inserting a medical implement only partially intothe passage, or even merely positioning the medical implement adjacentto, but not within, the slit 171. Thus, either the tip of the implementor the pressure of the fluid flow breaks contact of the sidewalls 177,179 at the slit 171 to open the valve. Advantageously, where partialinsertion of, or merely adjacent contact with, a medical implement isperformed, the valve member 153 may exhibit positive flowcharacteristics as the interior volume of the passage 175 in theundisturbed state is smaller than the interior volume of the passage 175in the partially inserted state.

Furthermore, if, as in the illustrated flexible member 83, the passage175 does not configured to provide positive flow characteristics oncomplete insertion of a medical implement, the passage 175 of theflexible member 83 need not include a region of relatively larger width.Thus, the passage 175 and the lateral extensions 169 of the flexiblemember 83 can be relatively narrow. Correspondingly, the housing canhave a relatively smaller diameter as compared with a positive flowmedical connector. Thus, a reduction in materials costs and connectorweight could be achieved with a non-positive flow embodiment of flexiblemember 83.

Embodiments of methods for making the valve member 14 of the flexibleconnectors 80, 81 will now be discussed with reference to FIGS. 12-18.In general, a valve member 14 for use in the present system can be madeaccording to any suitable process available to those of skill in thisfield. In some advantageous embodiments, the valve member 14 is built bymolding first and second “pre-forms” 130 which are then placed face toface within a second mold. The pre-forms 130 are then over-molded in aseparate molding process to form an integral flexible member 80 withvalve member 14 and sleeve 20 portions such as those shown and describedherein.

In one embodiment, a valve member 14 can be molded according to thegeneral process described in U.S. Patent Application Publication No.2004/0006330. A pair of preforms are molded between first and secondmold pairs. After this initial molding step, the mold halves with thepreforms still positioned therein, are pressed together with an overmoldplate positioned between the mold halves. The overmold plate isgenerally configured to produce the final shape of the valve member 14.With the mold apparatus (including the preform mold halves and overmoldplate) fully assembled, additional uncured material is then injectedinto the mold apparatus to fill the additional space in the mold cavitycreated by the overmold plate, thereby forming the remainder of thevalve member 14. In some embodiments, the overmolding method describedin the '330 publication can be adapted to form a valve member 14 with anintegral sleeve as described herein. Alternatively, a valve member 14can be molded according to the method of the '330 patent, and a sleeve20 can be subsequently joined to the valve member 14 by any suitableprocess such as molding, welding, or adhesives.

Another embodiment of an overmolding method is provided with referenceto FIG. 15. According to this method, preforms 130 are molded andcompletely removed from their molds prior to performing an overmoldingor joining step. FIG. 15 illustrates one embodiment of a preform 130 foruse in forming a valve member 14. Each preform 130 has a generallyplanar face 132 that, in the completed valve member 14, forms a wall ofthe slit 94. A flange portion 134 is also integrally molded with eachpreform 132. The sides of the flange portion 134 can be set back fromthe face 132 of the planar portion in order to provide a space 136 forovermold material to flow between and connect the flange portions 134 oftwo preforms 130. The molding of the preforms 130 is typicallyaccomplished by injecting a thermoset material into the cavity formedbetween the mold pairs and heating the molds and/or material to the settemperature of the specific material used. Pressure may be applied asneeded to prevent material from leaking between the halves of thepreform mold (not shown). In some embodiments, the preforms 130 can beprovided with dimples 110 on a back side 138 opposite the face 132.

After each preform 130 is molded, it can be removed from the preformmold and placed into an over-mold. The over-mold is generally configuredto form a final desired valve member/sleeve structure 80. In someembodiments, an overmold comprises first and second halves. Each halfcan comprise pins configured to locate the preforms 130 in the overmoldby aligning the pins with dimples 110 in the preforms 130.

Once the preforms are properly located in the overmold halves, theovermold halves can be brought together and an uncured overmoldingmaterial can be injected into the mold cavity. In some embodiments, theadditional (overmolding) material is injected soon (i.e., a few seconds)after the preforms 130 are molded and while they are still somewhat hotfrom their initial molding. The additional material injected into themold cavity bonds to the edges of the preforms 130 and forms the edgesof the slit 94 in the completed valve member 14 and sleeve 20. In thisway, the remainder of the valve member 14 and the sleeve 20 areovermolded and integrally formed with one another and with a pair ofpreforms during the over-molding step.

In some embodiments, the preforms 130 are pressed together withsufficient force during the overmolding process to prevent theovermolding material from migrating between the contacting surfaces ofthe preforms 130. This preserves the patency of the slit 94 bypreventing the contacting faces of the preforms 130 from bonding to eachother during the overmold step.

In other embodiments of this method, additional material is allowed toflow between and bond the contacting faces of the preforms to oneanother. Subsequently, the valve member 14 can be re-opened by insertinga blade between the preforms, thereby cutting open the slit 94. In stillanother embodiment, the entire valve member/sleeve structure can bemolded in a single process (i.e. without a pre-formed slit), and a slit94 can be subsequently formed by inserting a blade into a solid valvemember section. In another alternative embodiment, a sleeve 20 and valvemember 14 can be individually pre-formed and subsequently attached toone another, such as by overmolding, welding or with adhesives.

In some embodiments, the material added in the overmold step is similarto that utilized in molding the preforms 130. However, in otherembodiments the preform matrial and the overmold material may comprisedifferent but nonetheless suitable materials for manufacturing the valvemember 14 and sleeve 20.

In general, the sleeve 20 is typically made of a material withsufficient flexibilitly to allow the sleeve 20 to be inverted andstretched around the housing 12, and sufficient resilience to tightlygrip the housing 12 in the inverted orientation. Similarly, the valvemember 14 is typically made of a material that is sufficiently flexibleto allow a cannula to be inserted therein to open the slit, and also hassufficient resilience to re-close the valve member 14 once the cannulais withdrawn. In some embodiments, the valve member 14 and the sleeve 20are unitarily formed of an elastomeric material such as silicone rubber.In one preferred embodiment, the valve member 14 and sleeve 20 areintegrally molded from 50 durometer silicone rubber. Alternatively, thevalve member 14 and sleeve 20 can be made of synthetic polyisoprene,other silicone rubber and/or urethane formulations, or other materialsacceptable for medical use. In some embodiments, the sleeve 20 can bemolded from a first material, and the valve member 14 can be molded froma second, different material.

Some embodiments of a flexible member 83 (FIGS. 19-21) not includingpositive flow characteristics can be more efficiently manufactured. Themanufacture of a flexible member 83 as illustrated in FIGS. 19-21 can beaccomplished with fewer steps and, accordingly, lower costs than otherembodiments featuring positive flow functionality. The relatively smallregion of contact between the sidewalls 177, 179 facilitates manufactureof the flexible member 83 embodiments illustrated in FIGS. 19-21.

With reference now to FIGS. 22-25, embodiments of a method of assemblinga soft grip medical connector 10 will be described. The valve member 14can be inserted into the upper housing cavity 42 portion of the housing12 by partially folding or compressing the lateral extensions 84 inwardsand pushing the valve member 14 into the upper housing cavity 42 untilthe compressed or folded lateral extensions 84 reach the slots 46 andare permitted to uncompress or unfold and extend through the slots 46 tothe outside of the housing 12. In some embodiments, tooling can beemployed to grasp the lateral extensions 84 and pull the valve member 14into the upper housing cavity 42. In some of these embodiments, the toolcan be configured to engage the dimples 110 in the lateral extensions 84to grasp and pull the valve member 14. As the lateral extensions 84 arealigned and pulled or pushed through the slots 46, an additionaldownward force can be applied to slightly stretch the valve member 14and allow the shoulders 92 to engage the top edges 140 of the slots 46.In this way, a preload (discussed in further detail below) can beapplied to the valve member 14. This downward force also allows the leadlumen to more securely engage the interior cannula 50 within the housing12.

Once the valve member 14 is fully inserted into the upper housing 40(e.g. as shown in FIG. 25), the sleeve portion 20 can be inverted andstretched over the housing 12. This can be accomplished using anysuitable tooling. The sleeve 20 can also be grasped by a person'sfingers and pulled outwards and downwards in the direction of the arrows146 in FIG. 23. As the sleeve 20 is inverted, the protrusions 120 willgenerally align with the spaces between the rings 60 of the housing 12.If provided, the windows 126 will also be aligned with the protrusions70 so that the protrusions 70 pass through and extend beyond theflexible member 80.

When a cleaning solution or other liquid is applied to the medicalconnector 10, the liquid may seep around the protrusions 70 between thesleeve 20 and the housing 12, thus causing the sleeve to slip relativeto the housing 12 and making it more difficult for a health careprofessional to grip the outside surface of the medical connector 10. Toreduce the risk that the sleeve 20 will slide or separate from thehousing 12, the sleeve 20 can be adhered to the housing 12.Additionally, in various embodiments, the sleeve 20 may be stretchedover an annular groove 54 (FIG. 24) or sandwiched in a space 61 betweenhousing portions 41, 51 (FIGS. 10, 11) to reduce the risk of slippage.Before the sleeve 20 is inverted and stretched over the housing 12, anadhesive can be applied to the housing 12 or the sleeve 20 in a locationof contact between the sleeve 20 and the housing 12 of an assembledconnector 10. For example, in certain embodiments, the housing mayinclude a recess 73 (FIG. 11) adjacent the Luer lugs 71 to whichadhesive may be applied. Alternatively, adhesive may be spread over anouter surface of the housing 12.

Preferably, the housing 12, sleeve 20, and adhesive are chosen ofcompatible materials to reduce the risk of material degradation due tothe application of adhesive. For example, the sleeve 20 can beconstructed of a silicone rubber, to be bonded with the housing 12 witha silicone-based adhesive such as an adhesive comprisingdimethylpolysiloxane. In certain embodiments, the adhesive may requirethe mixture of two components, at least one of which includes a catalystsuch as a platinum-based catalyst. In certain embodiments, the adhesivemay require curing such as, for example, by heating the adhesive to apredetermined temperature for a predetermined time. For materialcompatibility with a silicone-based adhesive, the housing 12 can beconstructed of a glass-reinforced thermoplastic polyester resin, suchas, for example, glass-filled Valox® including approximately 30% glassfill, produced by General Electric Company. In some embodiments, thehousing 12 can be constructed of a polycarbonate material, although insome situations the polycarbonate may not be compatible with asilicone-based adhesive.

FIGS. 24 and 25 illustrate cross-sectional views of embodiments of afully assembled soft grip medical connector 10. In the illustratedembodiment, the sleeve 20 filly surrounds the housing 12 including theupper housing 40, the rings 60, and a substantial portion of the Luerskirt 52. But, it is contemplated that in other embodiments, the sleeve20 may extend over a portion of the housing 12. For example, in certainembodiments, the sleeve may extend from the upstream end 16 of thehousing 12 downward over between approximately one-half a height of theupper housing 40 and the entire upper housing 40. In other embodiments,the sleeve 20 may extend from the upstream end 16 of the housing 12downward over between approximately one-fourth the height of the upperhousing 40 to one-half the height of the upper housing 40. Likewise, inembodiments of medical connector 10 including a two-piece housing, asillustrated in FIGS. 7-11, in various embodiments, the sleeve 20 cansurround a portion of the first housing portion 41, substantially all ofthe first housing portion 41, all of the first housing portion and aportion of the second housing portion 51, or all of the first housingportion and substantially all of the second housing portion 51. Thesleeve 20 can also surround the lateral extensions 84 extending throughthe slots 46 of the housing 12.

FIGS. 24 and 25 illustrate an example of an assembled connector in asealed state (i.e., in which fluid flow through the connector isimpeded). The valve member 14 is positioned within the upper housingcavity 42 of the housing 12, with the first and second lateralextensions 84 of the valve member 14 protruding from the first andsecond slots 46 in the housing 12. The lead lumen 102 of the valvemember 14 is positioned so that the interior cannula 50 extends at leastpartway into the lead lumen 102 of the valve member 14, facilitatingfluid communication between the valve member 14 and the Luer cannula 32when the connector is in the open state (as illustrated in FIGS. 15 and16). The flange 90 covers the axial opening at the upstream end 16 ofthe housing 12.

The sleeve 20 on the outside surface of the housing 12 allows healthcare providers to more comfortably and effectively grasp the connector10. The flexible material of the sleeve 20 provides a softer surface forthe fingers. There is preferably a high-friction interface between theflexible material of the sleeve 20 and the rubber gloves typically wornby health care providers, requiring less finger-pinching effort to screwthe connector 10 onto a catheter or other medical implement and tomaintain the connector 10 in a desired position and orientation duringthe connection and fluid-administration processes.

In addition to providing a soft, easily grippable outer surface, thesleeve 20 surrounding the exterior of the housing 12 protects thelateral extensions from being pinched or otherwise undesirablymanipulated during handling and use of the connector. In one embodiment,the valve member 14 and housing 12 are constructed such that thedistance between the upstream end 16 and the top edges 140 of the slots46 of the housing 12 is slightly larger than the distance between theflange 90 and the shoulders 92 of the lateral extensions 84 of the valvemember 14. This arrangement results in the application of a tensileforce or preload to the valve member 14 between the flange 90 and thelateral extensions 84.

The preload arises as the shoulders 92 bear against the top edges 140 ofthe housing and the seal flange 90 bears against the upstream end 16and/or the shoulder 142 of the axial opening at the upstream end of thehousing. In some embodiments, the preload causes the flange 90 to assumea slightly bowl-shaped or concave configuration as the edges of theupstream housing end 16 bear against the underside of the flange 90. Thebowl-shaped flange 90 tends to more tightly pinch closed the slitopening 100 and thus enhances the ability of the valve member 14 toprevent fluid flow. The preload also prevents buckling of the valvemember 14 along its longitudinal axis and maintains the sides of theslit 94 in close proximity to each other along their entire length. Thepreload thus promotes a relatively thin slit 94 below the flange 90,which enhances the sealing performance of the slit 94. In someembodiments, a distance between the shoulders 92 and the opening 148 ofthe interior cannula 50 is sized such that the lead lumen 102 of thevalve member 14 will be engaged with and sealed to the interior cannula50 of the housing 12.

Referring now to FIGS. 26 and 27, during use of the connector 10, acannula 200 of a medical device 202, such a syringe, can be insertedinto the valve member 14 of the connector 10, thereby opening the valvemember 14 to fluid flow 204 between the medical device 202 and the Luercannula 32 of the connector 10.

Before the cannula 200 is inserted, the connector 10 is in a sealedstate (see, e.g., FIGS. 24 and 25). In this state, the slit 94 defines asubstantially closed or highly restricted flow path through the valvemember 14. As illustrated in FIG. 16, when the cannula 200 is insertedthrough the slit 94, the valve member 14 opens a fluid flow path withinthe connector 10 while exerting an inwardly directed force against thecannula 200 of the medical device 202, preferably forming a tight sealaround the circumference of the cannula 200 to prevent leakage of fluidthrough the upstream end of the connector 10. The insertion of thecannula 200 into the valve member 14 also causes the valve member 14 tostretch in the downstream direction over the interior cannula 50.

As fluid is injected from the medical device 202, through the cannula200, and into the interior space within the valve member 14, the spacebetween the slits walls 206 increases further and the slit walls 206expand further and lengthen further in the downstream direction. Thevalve member 14 thus selectively permits fluid 204 to flow between amedical device 202 on the upstream end of the connector 10 and a medicalimplement (not shown) to which the lower Luer connector 30 is attached.

As shown in FIGS. 26 and 27, when in an open state, the connector 10permits fluid flow 204 that is preferably substantially unobstructed andlinear. This generally allows the connector to achieve higher flowrates. In some embodiments, the fluid flow rates through the connector10 can exceed 600 cubic centimeters per minute. In addition, theunobstructed and linear fluid flow 204 interferes less with the inherentqualities of the flowing fluid 204. For example, if the fluid flow 204is blood, the various blood cells and other constituents are less likelyto break down within the illustrated connector 10 as compared to aconnector in which there is a circuitous fluid flow path with fluidturbulently strikes against hard and/or angular internal surfaces.

As the fluid flow 204 diminishes and/or the cannula 200 of the medicaldevice 202 is withdrawn from the valve member 14, the slit walls 206retract and return to their original configuration to once again definea narrow, restrictive path width between them (as illustrated, forexample, in FIGS. 24 and 25). This retraction of the slit walls 206causes the volume within the slit 94 to decrease to a certain minimum.The retracting action of the slit walls 206 also forces out theremaining fluid in the area between the walls 206. As the syringecannula 200 is being withdrawn, the displaced fluid cannot flow out ofthe slit 94 through the upstream end of the valve member 14 because thisspace is occupied by the syringe cannula 200. The resilient narrow neck97 of the slit 94 preferably blocks any significant flow of fluidbetween the outer surface of the cannula 200 and the inner surface ofthe flexible member 80 by forming a tight seal around the circumferenceof the cannula 200. Thus, the displaced fluid is instead forceddownwardly from the slit 94, through the interior cannula 50 anddownwardly directed cannula 32, and ultimately out of the housing 12.This advantageously results in automatic positive flow from theconnector 10 toward the patient upon withdrawal of the medical device202 from the upstream end of the connector 10, and avoids or minimizesretrograde fluid flow toward the connector 10 and away from the patient.

Although the foregoing description refers to a syringe, it iscontemplated that any type of suitable medical devices may be joined toeither end of the connector 10, such as IV bags, other connectors, andtubing, for the purposes of fluid transfer or for any other desiredpurpose. An auxiliary connector also may be connected to the soft gripconnector, and both connectors can be placed in fluid communication witha catheter with an end positioned within a patient. This arrangement canprovide several advantages in situations which call for the use of aunique auxiliary connector. For example, when it is necessary to replaceor reconfigure fluid lines connected to auxiliary connectors, such linesmay be removed from fluid communication with the catheter withoutcreating a backflow in the catheter, and replaced with a similarconnector or any other medical implement. In some embodiments, one suchauxiliary connector may be the CLAVE® connector sold by ICU Medical,Inc. However, any connector or other medical implement or device may beplaced in fluid communication with the soft grip connector 10 tointroduce fluid to the patient or to withdraw blood from the patientincluding, but not limited to, pierceable connectors, needle-lessconnectors, medical tubing, syringes or any other medical implement ordevice.

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of themethods and devices shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodiments.For example, the various embodiments of housing may be interchangeableapplied to the various embodiments of flexible member to achievemultiple embodiments of soft-grip medical connector. Additionally, itwill be recognized that the methods described herein may be practicedusing any device suitable for performing the recited steps. Suchalternative embodiments and/or uses of the methods and devices describedabove and obvious modifications and equivalents thereof are intended tobe within the scope of the present disclosure. Thus, it is intended thatthe scope of the present invention should not be limited by theparticular embodiments described above, but should be determined only bya fair reading of the claims that follow.

1. A medical connector for selectively permitting fluid to flow at highflow rates between a first medical device and a second medical devicehaving a standard medical Luer tip at a first end thereof, the medicalconnector comprising: a housing comprising an upstream end adapted toreceive the second medical device, a downstream end with an interfaceconfigured to receive the first medical device, an outer surface, a basemember with a generally annular surface, an upper housing cavityextending from the upstream end of the housing to the generally annularsurface of the base member, and an interior cannula extending from thegenerally annular surface toward the upstream end of the housing, theinterior cannula having a height defined by the distance between thegenerally annular surface and an upstream end of the interior cannulaclosest to the upstream end of the housing, the upstream end of thehousing having a substantially circular, substantially rigid, andsubstantially continuous periphery; and a valve member at leastpartially positioned within the housing, the valve member configured tocontrol a flow of fluid through the housing, the valve member comprisinga seal element made of a flexible material, the seal element having adownstream end, an upstream end configured to receive at least a portionof the second medical device, and a normally substantially closedpassage in fluid communication with the downstream end of the sealelement and the upstream end of the seal element, the seal elementcomprising a first sidewall and a second sidewall, the second sidewallgenerally opposing the first sidewall; wherein the medical connector isconfigured so that upon full insertion of a portion of the first end ofthe second medical device into an upstream end of the passage, thedistance between a lead surface of the Luer tip at the first end of thesecond medical device and the upstream end of the interior cannula isapproximately the same size as an inner diameter of the interiorcannula; wherein the valve member further comprises a lead lumen at thedownstream end of the seal element configured to fit over an outsidesurface of the interior cannula such that the downstream end of the sealelement is separated from the generally annular surface of the basemember by a first distance when the valve member is in a substantiallyclosed state, and wherein upon insertion of the first end of the secondmedical device into the upstream end of the passage, the downstream endof the seal element slides in a downstream direction along the outersurface of the interior cannula such that the downstream end of the sealelement is separated from the generally annular surface of the basemember by a second distance, the first distance being greater than thesecond distance; wherein the valve member further comprises a transverseflange having at least one slit opening therethrough in fluidcommunication with the passage; wherein at least one of the firstsidewall and the second sidewall comprises at least a portion having alateral thickness that is greater than a thickness of the transverseflange.
 2. The medical connector of claim 1, wherein the housingcomprises a first housing portion and a second housing portion.
 3. Themedical connector of claim 1, wherein the valve member further defines asubstantially unobstructed linear flow path when the second medicaldevice is inserted into the medical connector.
 4. The medical connectorof claim 1, wherein the first and second opposing sidewalls areconfigured to separate to expand the passage when a fluid is flowingthrough the valve member.
 5. The medical connector of claim 1, whereinthe passage is configured to selectively permit a substantiallyunobstructed flow of fluid therethrough at a flow rate of at leastapproximately 600 cubic centimeters per minute.
 6. The medical connectorof claim 1, wherein the medical connector is configured to selectivelypermit a substantially unobstructed, non-turbulent flow of fluidtherethrough.
 7. The medical connector of claim 1, wherein thesubstantially circular, substantially rigid, and substantiallycontinuous periphery of the housing extends from the upstream end towardthe downstream end of the housing.
 8. The medical connector of claim 1,wherein the medical connector is configured so that upon full insertionof the portion of the first end of the second medical device into theupstream end of the passage, the distance between the lead surface ofthe Luer tip at the first end of the second medical device and theupstream end of the interior cannula is less than the height of theinterior cannula.
 9. The medical connector of claim 1, wherein the sealelement comprises a neck portion positioned in a region near theupstream end of the seal element, the passage being relatively narrow inthe region of the upstream end of the seal element.
 10. The medicalconnector of claim 9, wherein the transverse flange extends from theneck portion towards the housing.
 11. The medical connector of claim 1,wherein the passage is adapted to have a relatively small interiorvolume when in a substantially closed state and a larger interior volumeupon the introduction of the second medical device into the upstream endof the seal element, the passage adapted to retract to define arestricted flow path and the relatively small interior volume upon thewithdrawal of the second medical device of the seal element, at least aportion of the upstream end of the seal element adapted to initiallypress against the inserted portion of the second medical device as thesecond medical device is withdrawn, so that a fluid occupying theinterior volume is forced toward the downstream end of the seal elementas the passage retracts.
 12. The medical connector of claim 1 furthercomprising a gripping portion.
 13. The medical connector of claim 12,wherein the gripping portion is disposed over at least a portion of theouter surface of the housing.
 14. The medical connector of claim 12,wherein the gripping portion is integrally formed with the valve member.15. The medical connector of claim 1, wherein the medical connectorcomprises a substantially hourglass-shaped profile.
 16. The medicalconnector of claim 1, wherein the upstream end and the downstream end ofthe housing are disposed on substantially the same axis to assist inproviding a substantially straight fluid-flow path through the medicalconnector.
 17. The medical connector of claim 1, wherein the firstsidewall and the second sidewall define a region of contact at theupstream end of the seal element at least when the valve member is in asubstantially closed state.
 18. The medical connector of claim 17,wherein the region of contact between the first sidewall and the secondsidewall is relatively small to facilitate opening of the medicalconnector.
 19. The medical connector of claim 1, wherein the passage hasa non-zero volume when the valve member is in a substantially closedstate.
 20. The medical connector of claim 1, wherein the upstream end ofthe housing and the downstream end of the housing are disposed onsubstantially the same axis to assist in providing a substantiallystraight fluid flow path through the medical connector, wherein thefirst sidewall and the second sidewall define a region of contact at theupstream end of the seal element at least when the valve member is in asubstantially closed state, the region of contact between the firstsidewall and the second sidewall being relatively small to facilitateopening of the medical connector, wherein the passage has a non-zerovolume when the valve member is in a substantially closed state, andwherein the passage is configured to selectively permit a substantiallyunobstructed flow of fluid therethrough at a flow rate of at leastapproximately 600 cubic centimeters per minute.
 21. The medicalconnector of claim 1, wherein at least one of the first sidewall and thesecond sidewall has a lateral thickness that increases in the downstreamdirection along the length of the seal element.
 22. The medicalconnector of claim 1, wherein the transverse flange bears on theupstream end of the housing such that the valve member is preloadedtowards a closed position.
 23. The medical connector of claim 22,wherein the valve member comprises one or more shoulders configured toengage one or more corresponding edges of the housing, wherein thedistance between the upstream end of the housing and the one or moreedges is greater than the relaxed distance between the transverse flangeand the one or more shoulders, such that the valve member is stretchedwhen the one or more shoulders engage the one or more edges causing thetransverse flange to bear on the upstream end of the housing.
 24. Themedical connector of claim 22, wherein the transverse flange has agenerally concave configuration to bias the slit opening towards aclosed position when in a substantially closed state.